DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (a solid method of compound I), in the reply filed on 07/17/2025 is acknowledged.
Claims 1-87, 92 and 116-126 are pending of which claims 82-87, 92, 118-121, and 123-126 in Group II-V, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 1-81, 117, and 122 have been examined on the merits.
Withdrawn Restrictions/Elections Requirement
The restriction for claims 82-87, 92, 116, 118-121, and 123-126 have been withdrawn, thus claims 82-87, 92, 118, 118-121, and 123-126 are now included for full examination on the merit.
Claim Rejections - 35 USC § 112 (Enablement)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 118-121 and 123-126 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 118, 120 and 125 are drawn to a method for treating a cancer in a patient or a method for inhibiting FGFR3 enzyme. However, the specification does not provide any experimental data or disclosure demonstrating the capability of a solid form of Compound 1 to achieve the therapeutic effects as claimed. The specification fails to provide data of any cancer patient who have been administered with the claimed compound to demonstrate therapeutic effectiveness to treat all cancer types or at inhibit FGFR3 enzyme or diseases thereof. In addition, the claim recites a broad genus “a cancer,” is intended to encompass all cancer types; no supporting data has been provided.
Thus, without appropriate data regarding therapeutic treatment, a person of ordinary skill in the art (POSITA) would not know whether the compound actually achieves the claim functions. For these reasons, a POSITA would also recognize that the absence of any available treatment data of a patient with cancer, suggest that the claimed compound may not be used for treatment as claimed, which then significantly weakens the enablement of the claimed invention. Therefore, the absence of such data supports the conclusion that the specification does not provide adequate disclosure to conclude that the compounds can serve as a potential therapeutic option for treatment or inhibiting FGFR3 enzyme.
Consequently, the lack of enablement of the claimed subject matter at the time of filing, suggest that Applicant did not possess supporting data to claim a method of therapeutic treatment option for a patient diagnosed with cancer.
112 (Written description)
Claims 118-121 and 123-126 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 118, 120 and 125 drawn to a method for treating a cancer in a patient or a method for inhibiting FGFR3 enzyme. The specification provides no guidance as to whether the claimed compound is effective against all cancer types, nor does it clarify whether the same effective amount applied uniformly across all cancer types. It is then recommended that the specification provides support for such a broad claim, “a cancer” by providing data of claimed compound as treatment or at inhibiting FGRF3 enzyme.
The specification’s failures to disclose details on any specific regarding the compound efficacy as treatment, or at inhibiting FGFR3 enzyme, further supports the conclusion that the specification lacks adequate written description of the claimed subject matter.
Allowable Subject Matter
The subject matter of claims 1-81, 116-117, and 122 are free of the art of record. The closest prior art is WO 2021/076602. While WO 2021/076602 teaches compound 1 of the instant claim, however there is no motivation for an ordinary skill in the art to modify the teaching of WO2021076602 to arrive at the claimed compound 1 Form 1, as an example.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622